510(k) K010228 ยท FTL Mesh, Surgical, Polymeric
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 21, 2001 |
| Received | Jan 24, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.